Model Number 7601-N90003-K |
Device Problem
Failure to Eject (4010)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/01/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Lot ndtt (2): device returned 21 september 2022.
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Event Description
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This record is a consolidation of q3 2022 records summarized as a part of the fda voluntary malfunction summary reporting program.This report captures two instance of intraoperative yukon navigated screw inserter jamming in which a physician had difficulty dissociating the tip of the inserter from the screw after screw insertion.The associated procedure was completed successfully with no surgical delay and no adverse consequence to a patient.
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Event Description
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This record is a consolidation of q3 2022 records summarized as a part of the fda voluntary malfunction summary reporting program.This report captures two instance of intraoperative yukon navigated screw inserter jamming in which a physician had difficulty dissociating the tip of the inserter from the screw after screw insertion.The associated procedure was completed successfully with no surgical delay and no adverse consequence to a patient.
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Manufacturer Narrative
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Lot ndtt (2): manufacture date 02 march 2021, device returned 21 september 2022.
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Search Alerts/Recalls
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